Kornimate/medical-research-clean huggingface dataset:
safety study of nexvax2 in subjects with coeliac disease

Conditions: Coeliac Disease; Celiac Disease

Summary: the main purpose of this study is to determine the safety of weekly injections of nexvax2 given for three weeks to patients with coeliac disease who have been on a gluten-free diet. the second purpose of this study is to compare the immune response over the three week study period in coeliac disease patients given nexvax2 compared to those given saline.


Eligibility criteria:
key inclusion criteria: 1. age 18 to 60 years (inclusive) 2. have coeliac disease meeting the following criteria: * the principal investigator is satisfied coeliac disease has been correctly diagnosed, * hla dq2 genotype (both hla dqa1\*05 and dqb1\*02, homo- or hetero-zygous), * no known or suspected gluten exposure for 2 months prior to enrolment * were prescribed and have intended to follow a gluten-free diet for at least one year * antibodies to tissue transglutaminase (ttg) iga and/or deamidated gliadin peptide (dgp) iga and igg within normal reference range at time of screening. 3. either male or non-lactating, non-pregnant females who are postmenopausal, sterile or using at least two acceptable and highly effective birth control methods. key exclusion criteria: 1. subjects possess the genes encoding hla dq8 (either dqa1\*03 or dqb1\*0302). 2. uncontrolled complications of coeliac disease which, in the opinion of the investigator, would impact immune response or pose an increased risk to the subject. 3. systemic biological agents less than 6 months prior to day 1. 4. receipt of systemic immunomodulatory agents or experimental drugs less than 30 days prior to day 1. 5. any of the following laboratory abnormalities at screening: * alt, ast or alkaline phosphatase (alp) \> 1.5 times the upper limit of normal (uln) * calculated creatinine clearance \< 80 ml/min * haemoglobin (hb) outside of the normal range * platelet count \<125 x 109/l * serum potassium outside of the normal range * white blood cell (wbc) count outside of the normal range * thyroid stimulating hormone (tsh) outside of the normal range * any other clinically significant abnormal lab values, as determined by the clinical investigator. 6. subjects who smoke or who have smoked at all in the past 3 months. 7. positive pregnancy test at screening or baseline. 8. history of any medically significant condition considered by the investigator to adversely affect participation in the trial. 9. non-compliance with a gluten free diet or flare in coeliac disease symptoms from screening to baseline. 10. clinically relevant abnormality on ecgs.
correlation between the efficacy of neoadjuvant chemotherapy combined with immunotherapy of operable thoracic esophageal squamous cell carcinoma and the metabolites of intestinal flora

Conditions: Esophageal Squamous Cell Carcinoma; Intestinal Flora

Summary: this study collects stool, blood, and tumor tissue samples from patients with locally advanced esophageal cancer after receiving sintilimab and chemotherapy to explore the efficacy and intestinal microbes of chemotherapy combined with neoadjuvant immunotherapy for locally advanced operable thoracic esophageal squamous cell carcinoma the main purpose is the relationship between its metabolites, and it will also explore the changes of intestinal flora diversity and metabolites before and after esophageal squamous cell carcinoma chemotherapy combined with immune neoadjuvant therapy


Eligibility criteria:
inclusion criteria: * 1) age ≥18 years old and ≤75 years old; 2) patients with stage i\~iii thoracic esophageal squamous cell carcinoma diagnosed by histopathological examination (excluding mixed adenosquamous carcinoma and other pathological types); 3) ecog ps score is 0 or 1; 4) it has sufficient organ and bone marrow function. exclusion criteria: 1. refuse to participate; 2. patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula; 3. have previously received anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137 or anti-ctla-4 antibody therapy, or any other antibodies targeting t cell costimulation or checkpoint pathways as specific targets or drug; 4. participate in another interventional clinical study at the same time, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study; 5. have received systemic systemic treatment with anti-tumor indications chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration; 6. have used immunosuppressive drugs within 1 week before enrollment, excluding nasal spray, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (ie no more than 10mg/day prednisone or equivalent doses of other glucocorticoids), or use hormones to prevent allergy to contrast agents.
to evaluate the efficacy and safety of ql1206 and xgeva in patients with bone metastases from solid tumors

Conditions: Bone Metastases

Summary: a multi-center, randomized, double-blind, comparative study to evaluate the clinical efficacy and safety of ql1206 and xgeva® in patients with bone metastases from solid tumors.

this is a multi-center, randomized, double-blind, comparative clinical trial. the primary objective is to evaluate whether the clinical efficacy of ql1206 and xgeva® are similar in patients with bone metastases from solid tumors. the secondary objective are to evaluate whether the clinical safety and immunogenicity of ql1206 and xgeva® are similar in patients with bone metastases from solid tumors.

Eligibility criteria:
inclusion criteria: 1. through the explanation of the researcher or the researcher's authorized representative, the subject has understood the nature and purpose of the study, as well as the research procedure, and the subject has signed the written informed consent; 2. radiologic evidence (i.e. x-ray examination, computed tomography ct, magnetic resonance imaging mri, positron emission computed tomography pet-ct) in grade iii grade a hospitals has been documented (within 3 months prior to study administration) that there is at least one bone metastasis; 3. the ecog score was 0-2. 4. chinese adults with solid tumor confirmed by histological or cytological examination (age ≥18 years, ≤80 years). exclusion criteria: 1. patients who had received any kind of intravenous or oral bisphosphonates before administration of the first study drug (those who had previously used an intravenous or oral bisphosphonates but had a continuous use time of less than 3 months and more than 5 years before the administration of this study could be included in the study). 2. previous treatment with denosumab. 3. previous or ongoing osteomyelitis or osteonecrosis of the jaw onj , active dental disease or jaw bone disease requiring oral surgery, the wound of dental operation or oral surgery has not healed well, or invasive dental operation has been planned during the study period. 4. plan to perform radiotherapy or or bone surgery. patients who received radiotherapy within one month before the first study drug administration were not allowed to be included.
a phase ii, trial of ixabepilone plus cetuximab as first line therapy for metastatic pancreatic cancer

Conditions: Metastatic Pancreatic Cancer

Summary: the purpose of this clinical research study is to learn if ixabepilone plus cetuximab improves survival when given as 1st line chemotherapy in subjects with metastatic pancreatic cancer compared to historical data. the safety of this combination treatment will also be studied.


Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of pancreatic adenocarcinoma (locally advanced disease that is not surgically resectable, or distant metastatic disease) * participants must have measurable disease as per response evaluation criteria in solid tumors (recist) guidelines * participants must not have received prior chemotherapy, immunotherapy or chemoradiotherapy for advanced pancreas cancer * karnofsky performance status (kps) of 70-100 * adequate hematologic, hepatic and renal function
threatened preterm birth and time of subsequent delivery -a prediction model

Conditions: Preterm Birth; Immunologic Activity Alteration

Summary: this study investigates immunological and clinical markers in threatened preterm birth aiming to create a prediction model for preterm birth.

preterm birth is the main cause of neonatal mortality and morbidity and despite a lot of effort the mechanisms leading to preterm birth are poorly understood. in threatened preterm birth it is difficult to identify the true high risk cases ultimately leading to preterm birth. these women are often overtreated. in this study blood samples are taken from women with threatened preterm birth and from women with normal pregnancies before and during labor. differences in clinical characteristics and immunological markers between the groups are studied in order to design a prediction model for preterm birth.

Eligibility criteria:
inclusion criteria: * threatened preterm birth before 34 weeks of gestation; either threatened preterm labor and/or preterm prelabor rupture of the membranes * age \> 18 years * swedish-speaking (understanding study information) exclusion criteria: * multiple gestation * blood borne infections
born in guangzhou intervention study

Conditions: Pregnancy Outcomes; Child Development; Pregnancy Complications

Summary: the main objective of this study is to test the efficacy of an intervention package (dietary, physical and lifestyle modification) during pregnancy in improving the clinical outcomes of mother-infant dyads.


Eligibility criteria:
inclusion criteria: * pregnant women attending prenatal care at guangzhou women and children's medical center (gwcmc) \<20 weeks' gestation * pregnant women plan to deliver at gwcmc * pregnant women intend to reside in guangzhou for at least 3 years exclusion criteria: * multiple pregnancies * existing medical conditions (uncontrolled diabetes, hypertension or thyroid disease; other serious cardiovascular diseases, respiratory or systematic disorders) * use of drugs (aspirin, metformin, low molecular weight heparin) * women with reading and/or writing difficulties * women with serious mental disorders * women with eating disorders
a study to assess the effect of maintenance treatment with rituximab versus no treatment in participants with progressive b-cell chronic lymphocytic leukemia (cll)

Conditions: Lymphocytic Leukemia, Chronic

Summary: this study will assess the effect of maintenance treatment with rituximab in comparison with observation period (no treatment), in participants with progressive b-cell cll who have had previous first-line induction treatment with rituximab, cladribine and cyclophosphamide (rcc regimen). after 6 months of rcc induction therapy, participants will be randomized either to receive maintenance treatment with rituximab or to receive no treatment (observation only) for 96 weeks. participants completing maintenance/observation period will be followed-up for approximately 3 years.


Eligibility criteria:
inclusion criteria: * immunologically confirmed diagnosis of b-cell cll * rai stage i-iv disease with evidence of progression * no previous chemotherapy, radiotherapy, or immunotherapy for b-cell cll * eastern cooperative oncology group (ecog) performance status of 0 to 2 exclusion criteria: * active secondary malignancy or transformation to aggressive lymphoma * medical condition requiring chronic use of oral corticosteroids at a dose of 1 mg/kg or 60 mg/m\^2 over 2 weeks * prior treatment with interferon, rituximab or another monoclonal antibody, immunosuppressive treatment or radiotherapy before inclusion to the study * history of other malignancies within 2 years before study entry, except for dequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ (dcis) of the breast treated with lumpectomy alone with curative intent
perimetry based on eye-movements in patients with (supra)sellar tumors

Conditions: Pituitary Tumor; Visual Fields Hemianopsia

Summary: the purpose of this study is to assess wether the sonda visual field test is suitable for patients with a supra sellar tumour.

the objective of this study is to determine whether sonda is non-inferior in predicting visual field limitations compared to the sap in patients with a (supra)sellar tumor. the study population will be made up of patients with a (supra)sellar tumor complicated by compression of the optic chiasm as well as healthy controls. the patients will be asked to join the study when the patients are referred to the umcg for further diagnostics and treatment. in case the patients show signs of visual field loss the patients will be asked to participate in the study. the researchers will reuse data from healthy controls collected in previous studies where possible and, if necessary for age matching, recruit new participants. participants will be asked to perform the sonda test before and after surgery. the first time the participants will perform the test twice and will also perform routine eye test and be asked to fill in a questionnaire to evaluate the experience.

Eligibility criteria:
inclusion criteria: * diagnosed with a (supra)sellar tumor * visual field loss based on the most recent sap; false positive rate \<15%; fixation losses \<20% * informed written consent exclusion criteria: * neurological disorders * eye disease not related to a (supra)sellar tumor
a study of gzr18 injection in chinese patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: this study was a multicenter, randomized, parallel and controlled study in adult patients with t2dm to evaluate the efficacy, safety (including immunogenicity) and pharmacokinetics of gzr18 injection in adult patients with t2dm.


Eligibility criteria:
inclusion criteria: * (1) chinese adults, male or female aged between 18 and 75 (including both ends). (2) according to the diagnostic and classification criteria of diabetes issued by the world health organization (who) in 1999, and the supplementary diagnostic criteria of who in 2011, type 2 diabetes was diagnosed for more than 3 months. (3) lifestyle intervention and / or unregulated use of antidiabetic drugs within 3 months before screening, or stable use of less than 3 oral hypoglycemic drugs within 3 months before screening. (4) hba1c (hba1c) ≥ 7.0% and ≤ 11% during screening. (5) body mass index (bmi) ≥ 18.5 kg/m2. (6) there is no birth plan within 6 months from the signing of informed consent to the last administration, and those who voluntarily take effective contraceptive measures and have no sperm donation plan. fertile women are not breastfeeding, and the screening and baseline pregnancy tests must be negative. (7) patients fully understand the purpose, nature, methods and possible adverse reactions of the trial, can communicate well with researchers, and can understand and comply with the requirements of this study. during the study, they can maintain a stable diet and exercise lifestyle, and voluntarily sign an informed consent form to enter this study. exclusion criteria: * (1) known or suspected to be allergic to glp-1 drugs or their excipients, or have contraindications to their use. (2) those who participated in clinical trials of other drugs or devices within 3 months before were screened and given treatment. (3) surgery that can lead to weight instability was performed within 2 months before screening, or non-diabetic drugs that affect weight are currently being used or are in the weight loss program and are not in the maintenance stage. (4) history of alcohol or drug abuse, or positive results of pre-random drug abuse screening (urine screening). (5) continuous use of insulin for more than 14 days in one year before screening (the time for gestational diabetes to receive insulin treatment is not within this limit); glp-1ra drugs were used in the first 6 months; dipeptidyl peptidase-4 (dpp-4) inhibitors were used in the first month. (6) growth hormone and other drug treatments determined by researchers to affect insulin levels were performed within 3 months before screening. (7) diabetic ketoacidosis, diabetic lactic acidosis or hyperosmotic nonketotic diabetic coma within 6 months before screening.
nivolumab combined with ipilimumab versus sunitinib in previously untreated advanced or metastatic renal cell carcinoma (checkmate 214)

Conditions: Advanced Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma

Summary: the purpose of this study is to compare the objective response rate, progression free survival and the overall survival of nivolumab combined with ipilimumab to sunitinib monotherapy in patients with previously untreated renal cell cancer.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * histological confirmation of renal cell carcinoma (rcc) with a clear-cell component * advanced (not amenable to curative surgery or radiation therapy) or metastatic (ajcc stage iv) rcc * no prior systemic therapy for rcc with the following exception: 1. one prior adjuvant or neoadjuvant therapy for completely resectable rcc if such therapy did not include an agent that targets vascular endothelial growth factor (vegf) or vegf receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy * karnofsky performance status (kps) of at least 70% * measurable disease as per response evaluation criteria in solid tumors (recist) 1.1 * tumor tissue \[formalin-fixed paraffin-embedded (ffpe) archival or recent acquisition\] must be received by the central vendor (block or unstained slides) in order to randomize a subject to study treatment. (note: fine needle aspiration \[fna\] and bone metastases samples are not acceptable for submission) exclusion criteria: * any history of or current central nervous system (cns) metastases. baseline imaging of the brain is required within 28 days prior to randomization * prior systemic treatment with vegf or vegf receptor targeted therapy (including, but not limited to, sunitinib, pazopanib, axitinib, tivozanib, and bevacizumab) * prior treatment with an anti-programmed death (pd)-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-cytotoxic t-lymphocyte antigen 4 (ctla-4) antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways * any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\>10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. subjects with vitiligo or type i diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll * any condition requiring systemic treatment with corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. inhaled steroids and adrenal replacement steroid doses \>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
clinical sensitivity of clearview rapid tests in 12-17 y/o pediatric population

Conditions: HIV Infections

Summary: this study is to establish the clinical sensitivity of the chembio diagnostics systems, inc. clearview complete hiv 1/2 assay and clearview hiv 1/2 stat-pak assay (clearview hiv tests) in pediatric subjects who are between 12 and 17 years of age. a minimum of ten (10) known hiv-positive participants will be tested.

in order to achieve the primary objective, clinical trials will be conducted to establish and confirm the sensitivity of the clearview hiv 1/2 tests in the described pediatric population. only hiv-1 will be included in the study. the clearview hiv tests can be used as a safe and effective screening method to aid in the diagnosis of infection with hiv 1/2 in the pediatric population aged between 12 and 17 years. the secondary objectives of this study include demonstrating that: - the clearview hiv tests detect hiv-1 antibodies in a variety of sample matrices: capillary (fingertip) whole blood, venous whole blood, plasma and serum.

Eligibility criteria:
inclusion criteria: * must be at least 12 years of age and no older than 17 years of age. * must be willing to sign (and be given) a copy of the written information and assent form. * must have a parent or guardian present to sign and receive a copy of the informed consent form. * must be able to provide one or two fingerstick blood samples. * must be able to provide three tubes of blood by venipuncture from the arm or hand only. exclusion criteria: * have a life threatening illness (with the exception of hiv or aids). * have a suppressed immune systems (i.e. transplant patients, individuals diagnosed with non-hiv immunosuppressive illness, etc.), as determined by interviewing the study participant or parent/legal guardian. * have participated or are participating in a clinical trial for an hiv vaccine (as determined by interviewing the study participant or parent/legal guardian). * have previously participated in this clinical trial (no duplicate enrollments). * are currently on haart, except as agreed on a case-by-case basis.

Keywords: hiv-1 infections